MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA HEAD LENS INT SYS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72203967

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that this new lens integrated camera head was found unsatisfactory performance due to ¿no video live signal¿ when it was connected to lens integrated system.

Manufacturer Narrative

There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of no live video output was confirmed.Cause of video malfunction is a defective interface pcb.Camera head passed functional testing with a known good interface pcb installed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

Event Description

It was reported that this new lens integrated camera head was found unsatisfactory performance due to ¿no video live signal¿ when it was connected to lens integrated system while tools were inside the patient.No patient injures were reported.

• Brand Name: CAMERA HEAD LENS INT SYS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7292099
• MDR Text Key: 100961246
• Report Number: 1643264-2018-00161
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556629833
• UDI-Public: (01)00885556629833
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203967
• Device Catalogue Number: 72203967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1